Bioscience innovation at risk from counter-productive laws

The BioIndustry Association (BIA), the trade association for innovative enterprises in the UK’s bioscience sector, would like to publicly endorse the sentiments expressed in François Lachappelle’s article ‘Rules for Rules’ Sake are Hindering Scientific Research’ (European Voice, 19-25 May) concerning the review of the directive that regulates the use of animals in medical research in Europe (86/609/EEC).

In a speech to mark the tenth anniversary of the European Medicines Agency on 11 March, Commissioner Günter Verheugen said: “Competitiveness drives innovation and innovation saves lives.” Research is the very lifeblood of the production of innovative medicines, which have the potential to save and improve the lives of millions of patients across Europe and worldwide. But crucially, the thrust of this review does not promote innovation.

We are deeply concerned that, as Lachappelle suggests, innovation within the market for European medicines could be hampered by increasing the levels of authorisation necessary and introducing a centrally mandated, highly prescriptive and detailed system for ethical review. Bioscience innovation is especially at risk from delays introduced here.

Such an increase in regulation would not lead to true advances in animal welfare, merely a more administrative system which obstructs researchers from carrying out research into life-saving medicines and restricts the competitiveness of the European medicines industry. Ultimately patients will be the losers, while the welfare of animals will not increase beyond the current high levels they have attained throughout Europe.

The EU’s institutions often lead the way towards supporting a positive environment for research. On this occasion, as Lachappelle’s article suggests, this review risks being utterly counter-productive. We urge all those involved in the review of the existing directive to look again.